STANDARD I-9

standard i-9: The organization has written policies and procedures to ensure that, when sharing oversight of research with another organization, the rights and welfare of research participants are protected.

An organization may rely on IRB or EC review, or other services, such as those of the contracting office or conflict of interest committee, of another organization to supplement its resources. Relying upon the services of one or more other organizations can facilitate research and increase the efficiency and cost-effectiveness of review.

There are multiple models of how organizations work together to share resources: reliance agreements, such as with an independent IRB or EC; reliance upon a central IRB or EC; reliance upon a lead IRB or EC; participating in a group of organizations that form a joint IRB or EC; assuming the role of a reviewing IRB or EC; or some combination of options. The options may be used for review of a single study or for review of all research, and organizations may decide to implement multiple options rather than having to select only one model. Regardless of the approach, the roles and responsibilities of each organization must be described in a written agreement.

If an organization relies on the services of another organization, policies and procedures must describe the steps followed to ensure that the reviewing IRB or EC, or other service, protects the rights and welfare of human research participants. Unless explicitly ceded to the reviewing IRB or EC, the organization retains the organization’s responsibilities defined in Domain I, such as control of investigational drugs.

Relying upon an AAHRPP-accredited IRB or EC ensures the reviewing IRB or EC meets accreditation standards. If the organization relies upon a non-accredited IRB or EC, it should ensure the IRB or EC provides appropriate human participant protections, given the risks of the research.

Some services may be provided by either the relying organization or the reviewing IRB or EC; policies and procedures or a written agreement must define shared responsibilities. AAHRPP strongly supports the notion that resources devoted to the evaluation and management of research – whether internally or externally reviewed – should be calibrated appropriately according to the risks posed by the research. This extends to the content, assessment, and implementation of reliance agreements that the written policies and procedures required under this standard are designed to address. Standards and Elements cited below highlight areas where existing policies may need to be revised to address single IRB or EC review. Requirements listed below describe requirements for IRB or EC review; however, similar considerations exist concerning other shared services.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(2), 45 CFR 46.103(d), 45 CFR 46.109(d), 45 CFR 46.114
DoD: DoDI 3216.02 3.5
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
FDA: 21 CFR 56.109(e), 21 CFR 56.114, FDA Information Sheet: Non-Local IRB Review, and Information Sheet: Cooperative Research
NIH: Policy on the Use of a Single Institutional Review Board for Multi-Site Research (June 20, 2016)
ICH-GCP: 4.2.3
VA: VHA Directive 1200.05(3), VHA Directive 1058.01, VHA Directive 1058.03
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Single IRB or EC Review

Required written materials

Essential requirements for IRB or EC review:
1. For AAHRPP-accredited HRPPs that provide IRB or EC review services to other entities, the relied upon organization must have policies and procedures that describe the roles of the reviewing IRB or EC, including:
  1. Ensuring the structure and composition of the IRB or EC is appropriate to the research reviewed and complies with applicable laws. This includes ensuring the IRB or EC is properly constituted; members are appropriately qualified; that members do not participate in the review of studies in which they have a conflict of interest; and the IRB or EC follows policy to separate business functions from ethics review services. (Standard II.1)
  2. Conducting review of research to determine that research is ethically justifiable, according to all applicable regulations and laws, including initial review, continuing review, and review of modifications to previously approved research. (Standards II.2, II.3, and II.4)
  3. Conducting review of the addition of investigative sites to previously approved protocols. The IRB or EC may decide to review these additions as separate protocols or as modifications to previously approved research, and they may decide to handle such modifications using the expedited procedure rather than the convened IRB or EC for review. When the expedited procedure is used, the IRB or EC must specify the criteria for when the addition of an investigative site is considered to be a minor modification. (Element II.2.F.)
  4. Ensuring the IRB or EC has the final authority to decide whether researcher or research staff conflict of interest and its management, if any, allows the research to be approved. (Element I.6.B.)
  5. Reviewing unanticipated problems involving risks to participants or others. (Element II.2.G.)
  6. Suspending or terminating IRB or EC approval. (Element II.2.H.)
  7. Notifying the researcher, and if applicable the organization, of its decisions, consistent with any reliance agreement. (Element II.2.E.)
  8. Making available relevant IRB or EC records, including but not limited to minutes, approved protocols, consent documents, and other records that document the IRB’s or EC’s determinations to the relying organization upon request. (Element II.5.A.)
  9. Having authority to request an audit of research being reviewed. (Element I.5.A.)
  10. Making relevant IRB or EC policies readily available to the relying organization, including HRPP staff, and researchers and research staff, and having a mechanism for communicating to the organization when policies are updated, as appropriate. (Element I.1.D.)
  11. Specifying the contact person and providing contact information for the reviewing IRB or EC for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the IRB or EC. (Element I.5.C.)
2. For AAHRPP-accredited HRPPs that rely on another organization’s IRB or EC, the relying organization’s policies and procedures must describe the roles of the organization and researchers when relying upon another organization’s IRB or EC, including:
  1. Specifying which studies are eligible for review by another organization’s IRB or EC, and describing the mechanism for making the determination. (Element I.1.A.)
  2. Ensuring, through education or other support, that researchers understand which activities are eligible for review by another IRB or EC. (Element III.1.A.)
  3. Ensuring that researchers are knowledgeable about the need to obtain any approvals from their own organization prior to seeking review by another IRB or EC, and that researchers know when to seek guidance. (Element III.1.A.)
  4. Complying with the determinations and requirements of the reviewing IRB or EC. (Element III.2.C.)
  5. Providing the reviewing IRB or EC with requested information about local requirements or local research context issues relevant to the IRB’s or EC’s determination, prior to IRB or EC review.
  6. Notifying the reviewing IRB or EC when local policies that impact IRB or EC review are updated. (Element I.1.D.)
  7. Ensuring that officials of the relying organization may not approve the research subject to the reliance agreement if it has not been approved by the reviewing IRB or EC. (Element I.1.C.)
  8. Acknowledging that researchers must cooperate in the reviewing IRB’s or EC’s responsibility for initial and continuing review, record keeping, and reporting, and that all information requested by the reviewing IRB or EC must be provided in a timely manner. (Element II.2.D.)
  9. Requiring researchers and research staff disclose conflicts of interest according to the process agreed upon between the organization and reviewing IRB or EC, and comply with any conflict of interest management plans that may result. (Element III.1.B.)
  10. Reporting promptly to the reviewing IRB or EC any proposed changes to the research. The investigator cannot implement changes to the research (including changes in the consent document) without prior IRB or EC review and approval, except where necessary to eliminate apparent immediate hazards to the participants. (Element III.2.C.)
  11. Ensuring researchers will not enroll participants in research prior to review and approval by the reviewing IRB or EC, and meeting all other applicable requirements and approvals for the study. (Element III.1.E.)
  12. Ensuring that researchers, when responsible for enrolling participants, will obtain, document, and maintain records of consent for each participant or each participant’s legally authorized representative. (Element III.1.F.)
  13. Reporting promptly to the reviewing IRB or EC any unanticipated problems involving risks to participants or others according to the requirements specified in the reliance agreement. (Element III.2.D.)
  14. Ensuring researchers provide to the reviewing IRB or EC data safety monitoring reports they receive, according to the IRB’s or EC’s reporting policy. (Element III.2.D.)
  15. Ensuring reporting of non-compliance, participant complaints, protocol deviations or other events according to the requirements specified in the reliance agreement. (Elements I.5.D., II.2.G, II.2.H., and III.2.D.)
  16. Conducting monitoring in addition to, or in cooperation with, the reviewing IRB or EC, when appropriate. (Element I.5.D.)
  17. Specifying the contact person and providing contact information for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the use of the reviewing IRB or EC. (Element I.5.C.)
  18. Ensuring researchers and research staff have appropriate qualifications and expertise to conduct the research, are knowledgeable about laws, regulations, codes and guidance governing their research, and are knowledgeable about the organization’s policies and procedures. (Element III.2.A.)
3. When there is a reliance relationship for IRB or EC review, a written agreement or policies and procedures must describe whether the organization conducting the IRB or EC review, or the relying organization, is responsible for the following:
  1. Providing education to researchers and research staff. (Element I.1.E.)
  2. Conducting scientific review. (Element I.1.F.)
  3. Reviewing potential non-compliance, including complaints, protocol deviations, and results of audits:
  4. Identifying which organization is responsible for deciding whether each allegation of non-compliance has a basis in fact.
  5. Identifying which organization’s process is used to decide whether each incident of non-compliance is serious or continuing. (Element I.5.D.)
  6. Obtaining management plans for researcher and research staff conflicts of interest. If the relying organization maintains responsibility for this issue, the management plan must be provided to the IRB or EC in a timely manner prior to the decision by the IRB or EC. (Element I.6.B.)
  7. Managing organizational conflict of interest related to the research. (Element I.6.A.)
  8. Ensuring that, should termination of a reliance agreement occur, one of the parties clearly is responsible for continued oversight of active studies until closure or a mutually agreed upon transfer of the studies.
When following DHHS and FDA regulations, policies and procedures or a written agreement must define the responsibilities of the relying organization and reviewing IRB or EC, including but not limited to:
1. Determining whether the relying organization applies its FWA to some or all research, and ensuring the IRB or EC review is consistent with requirements in the relying organization’s FWA.
2. Determining which organization is responsible for obtaining any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners.
3. Determining which organization is responsible for reporting serious or continuing non-compliance; unanticipated problems involving risks to participants or others; and suspensions or terminations of IRB or EC approval. Reporting may be done by the reviewing IRB or EC, the relying organization, or jointly, but must be clearly defined in policies or a written agreement. (Elements I.5.D., II.2.G., II.2.H., and III.2.D.)
4. When following NIH policy, policies and procedures must describe responsibilities for single IRB review, including:
5. Defining “authorization agreements” as the agreement, also called a reliance agreement, which documents respective authorities, roles, responsibilities, and communication between an organization providing the ethical review and a participating organization relying on a reviewing IRB.
6. Specifying in policies and procedures:
  1. That the requirement for single IRB review applies to awardees in the United States and participating research sites in the United States.
  2. That the requirement for single IRB review does not apply to organizations outside the United States.
  3. That awardee organizations are responsible for ensuring authorization agreements are in place, and that documentation is maintained.
  4. Who is responsible for meeting the additional requirements of the NIH Genomic Data Sharing Policy. (Element II.2.E.)
  5. That participating sites are expected to rely on the single IRB, though they may conduct their own review in accordance with NIH policy on exceptions from single IRB review.
When following DoD regulations, when serving as the reviewing IRB for a DoD-covered research study, policies and procedures or a written agreement must define the responsibilities of the DoD organization and non-DoD reviewing IRB, including but not limited to:
1. DoD institutions collaborating with non-DoD institutions may rely on a collaborating non-DoD institution’s IRB if the following conditions are met:
When following DOE requirements:
1. Research involving human participants involving multiple DOE sites (e.g., members of the research team from more than one DOE site and/or data or human subjects from more than one DOE site) must be reviewed and approved by one of the Central DOE IRBs prior to initiation, unless review by another appropriate IRB of record is authorized by the DOE and/or NNSA HSP Program Manager.
2. If authorized by the DOE and/or NNSA HSP Program Manager, research may be reviewed by other appropriate IRB of record. In all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR and the organization responsible for IRB review.
When relying upon an IRB or EC that is not AAHRPP-accredited, policies and procedures must also define:
1. The process ensuring research is being reviewed appropriately and complies with applicable law and regulations.
2. Criteria describing the extent of the review to confirm compliance with the organization’s ethical standards and with applicable law and regulations. The extent of the review of the non-accredited IRB or EC can vary, depending upon the level of risk to participants in the research.
When additional reviews relevant to the HRPP are conducted by an external organization, including but not limited to biosafety review, radiation safety review, recombinant DNA research review, human stem cell research review, and conflict of interest review, the relying organization must have policies and procedures describing:
1. How the review is documented and communicated to the IRB or EC or other relevant part of the HRPP. (Element I.1.F.)
2. The process for the relying organization to inform the external organization of circumstances when the external review must take into account additional regulatory requirements, for example, those of DoD or DOJ. (Element I.1.F.)
3. Education for researchers when using these additional reviews. (Element I.1.E.)
When following VA requirements:
1. For VA facilities:
  1. The VA facility’s IRB of record may include:
    1. The facility's own IRB(s)
    2. VHA Central Office IRB (VA Central IRB)
    3. An IRB of another VA facility
    4. The IRB(s) of a medical or dental school
    5. The IRB of another Federal agency
    6. An IRB for multi-site protocols that has been specifically designated by VA Office of Research and Development (ORD) as an IRB that may serve as a multi-site IRB for VA facilities
    7. A commercial IRB if it has been specifically designated by ORD as a commercial IRB that may serve as an IRB for cooperative research
  2. Documentation specifying the responsibilities that the VA facility and an organization operating as the VA facility's IRB of Record each will undertake to ensure compliance with the requirements of VHA Directive 1200.05, such as a Memorandum of Understanding (MOU) or an IRB Authorization Agreement or IRB reliance agreement.
  3. The VA medical facility Director is responsible for ensuring that documents (e.g., standard operating procedures (SOPs) or memoranda of understanding (MOUs)) establishing the role of a non-VA operated research review committee in the oversight of a VA medical facility’s research address the non-VA operated committee's procedures for the review and reporting (including to VA medical facility personnel) of events described in this directive, including timeframes. If the procedures of the non-VA operated committee differ from, or the timeframes exceed those of, VHA Directive 1058.01, the Director must consult with VA ORD and the appropriate VA Office of Research Oversight (ORO) workgroup (as specified on ORO's website) as to the adequacy of those procedures to protect the interests of VA and those involved in VA research.
  4. A VA facility’s own internal IRB, and the VA Central IRB, cannot serve as an IRB of record for any non-VA entity except a DoD facility, DOE Laboratory, or a VA-affiliated Nonprofit Research and Education Corporation (VA NPC). interests of VA and those involved in VA research.
2. When serving as a reviewing IRB for VA research:
  1. All IRBs overseeing VA human participants research must meet all the IRB requirements described in 38 CFR Part 16.
  2. When the IRB of Record is directly operated and supported by a non-VA entity, the policies and procedures related to the review of VA research by the non-VA entity must be consistent with VHA Directive 1200.05, 1005.01, and all requirements applicable to VA research.
  3. IRBs of Record used by a VA facility must hold current IRB registrations with HHS-OHRP.
  4. IRBs should consider including a Veteran or Veteran's representative.

Outcomes

The organization protects the rights and welfare of participants when collaborating with other organizations for oversight of research.

Proceed To: DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE

Evaluation Instrument for Accreditation

INTERNATIONAL ADDENDA

INTRODUCTION

TABLES

DOMAIN III: RESEARCHER AND RESEARCH STAFF

DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE

DOMAIN I: ORGANIZATION

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

STANDARD I-9